Medical Journal Article Highlights Technology’s Potential to Detect Heart Attack Risk at Home

HeartBeam Inc. is touting a peer-reviewed article that indicates a risk prediction algorithm incorporating its credit card-sized HeartBeam ECG device can accurately identify heart attack risk in patients experiencing chest pain.

Appearing in JACC: Advances, a journal of the American College of Cardiology, the article is titled, “Acute Coronary Syndrome Risk Prediction Using Portable Cable-Free ECG Device Combined With Clinical Risk Assessment.” The study was led by Alexei Shvilkin, M.D., Ph.D., clinical cardiac electrophysiologist at Beth Israel Deaconess Medical Center in Boston. The goal of this proof-of-concept study was to determine whether a risk score combining HeartBeam ECG data with patient risk factors and symptoms could accurately identify patients with chest pain who were at high risk for heart attack compared to an expert physician panel.

“This study is an important piece of the scientific foundation we are building toward heart attack detection as a future indication for the HeartBeam System,” HeartBeam CEO Robert Eno stated. “The results demonstrate that a clinical-grade ECG provided by our device, combined with a patient’s clinical history and symptoms, can deliver risk assessment comparable to physician evaluation with a traditional 12-lead ECG. In practical terms, a patient experiencing chest pain could use the HeartBeam System at home, reducing hesitation to seek medical help, reducing time to intervention, and potentially improving outcomes in the event of a heart attack.”

One of the most persistent problems in heart attack care is reducing “symptom to door” times as patients experiencing chest pain often wait hours before seeking care due to uncertainty around symptoms. Current tools for assessing heart attack risk outside the hospital are limited. A standard 12-lead ECG, which remains the most reliable tool, requires bulky equipment and trained personnel that are only available in clinical settings.

The proof-of-concept study evaluated whether a risk prediction algorithm could close that gap by combining three independent inputs into a single risk score: an ECG from the HeartBeam device, a patient’s pre-existing cardiovascular risk factors, and a structured symptom assessment. Key findings include:

• The prospective study enrolled 212 patients presenting to the emergency department with chest pain with 184 patients included in the final analysis.
• When the algorithm used a single ECG reading from the HeartBeam device combined with the patient’s risk factors and symptoms, it achieved an AUC of 86.5%. AUC or area under the curve is a key measure of performance.
• When a personal, symptom-free baseline ECG previously recorded on the same HeartBeam device was available for comparison, AUC increased to 92.9%. This is an important finding, as physicians evaluating an ECG from the HeartBeam System will always have the patient’s baseline ECG for comparison, potentially increasing the ability to detect a heart attack.
• The algorithm’s false-positive rate was significantly lower than the physician panel (19.8% for algorithm vs. 55.6% for physician panel, P=0.004), indicating fewer patients would be sent unnecessarily to the emergency department.

The authors concluded that integrating clinical risk factors, symptom characteristics, and ECG data from the HeartBeam System into a single algorithm “may enable clinically meaningful ACS (heart attack) risk stratification at the early stages of chest pain” and could help shorten the time between symptom onset and treatment.

Heart attack detection represents a potential major expansion opportunity for HeartBeam addressing a U.S. population of more than 20 million high-risk patients. This study, combined with the ALIGN-ACS pilot study currently underway in Europe and enrolling ahead of schedule, advances and expands HeartBeam’s clinical program.

HeartBeam Inc. is a medical technology company attempting to transform the detection and monitoring of critical cardiac conditions. The company has developed the first cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians can identify cardiac health trends and acute conditions and direct patients to the appropriate care, all outside of a medical facility. HeartBeam’s 3D ECG technology received U.S. Food and Drug Administration (FDA) clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025.¹ The company holds more than 20 issued patents related to technology enablement.

Reference
¹ Cleared Indications for Use. The HeartBeam System with 12-Lead ECG synthesis software is FDA cleared for arrhythmia assessment only. The heart attack detection indication and algorithm are not FDA cleared and not available in the US or any other geography at this time. Refer to the company’s Cleared Indications for Use at https://www.heartbeam.com/indications for details on the intended use of its technology.